Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD
Dialysate Additive 10.4 grams Potassium Chloride to increase Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
PC10.4
In Commercial Distribution

  • B467PC104145 ()
  • B467PC104 ()

  • Weight: 10.4 Gram
PC12

  • Haemodialysis concentrate
Dialysate Additive 5.1 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
CC5.1
In Commercial Distribution

  • B467CC51220 ()
  • B467CC51 ()

  • Weight: 5.1 Gram
CC2

  • Haemodialysis concentrate
Dialysate Additive 15.7 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC15.7
In Commercial Distribution

  • B467CC157145 ()
  • B467CC157 ()

  • Weight: 15.7 Gram
CC10

  • Haemodialysis concentrate
Blue Diamond® seat cushion pad for added comfort whether at your desk or in a surgical suite. Fits on most chairs or stools.
David Scott Company
BD2630
In Commercial Distribution

  • 15060797552146 ()

  • Width: 16 Inch
  • Length: 18 Inch
  • Height: .675 Inch
BD2630

  • Operating table patient pressure distribution pad, reusable
Blumenthal Tapered Hydrodelineation Cannula, 25 Gauge, Angled 4mm from bend to tip at 45°, tip is tapered to provide easy insertion, 22mm tip length
Diamatrix
C379
In Commercial Distribution

  • 00813059015419 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Melles DSAEK PLK Scraper, Style 2, 90° Angled tip, Angled 11mm from bend to tip at 90°, Diamond knurled handle, 125mm total length, Stainless.
Diamatrix
H305-2S
In Commercial Distribution

  • 00813059015303 ()


  • Ocular hook/spatula/manipulator, reusable
LIFE®SoftPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 255 liters of oxygen. Provides 40 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-2-101
In Commercial Distribution

  • B188LIFE21010 ()

  • Total Volume: 255 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 566 liters of oxygen. Provides 90 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-101
In Commercial Distribution

  • B188LIFE1010 ()

  • Total Volume: 566 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac is an easily portable, wall-mounted Emergency Oxygen Unit. A 0-25LPM, variable-flow regulator provides a 90 minute supply of oxygen at 6LPM.
Mv Life LLC
LIFE-025
In Commercial Distribution

  • B188LIFE0250 ()

  • Total Volume: 566 Liter


  • Fixed-regulator oxygen refillable cylinder
A menstrual cup is a feminine hygiene product that collects the menstrual fluid during menstruation. This DI has been created for use at Amazon.
LOON LAB INC.
LEONA AIR FLOW LARGE
In Commercial Distribution

  • 08809599750103 ()


  • Menstrual cup/disc, non-latex, reusable
A menstrual cup is a feminine hygiene product that collects the menstrual fluid during menstruation. This DI has been created for use at Amazon.
LOON LAB INC.
LEONA AIR FLOW SMALL
In Commercial Distribution

  • 08809599750097 ()


  • Menstrual cup/disc, non-latex, reusable
Hyde Colibri Forceps, 0.12mm, 2 x 2 Teeth, Three Hole Handle, Teeth Set At 45 Degrees, 7mm Tying Platform, Overall Length 4-1/8" (105mm)
Med Saver, Inc.
11-6-2031
In Commercial Distribution

  • 00194613082949 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Harms Style Colibri Forceps, 0.12mm, 1 x 2 Teeth, Three Hole Handle, Teeth Set At 45 Degrees, Tying Platform, Overall Length 4-1/8" (105mm)
Med Saver, Inc.
11-6-2013
In Commercial Distribution

  • 00194613082925 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Gills-Welsh Vannas Micro Scissors, Angled Forward, 8.5mm Blades, Sharp Tips, Angled At 40 Degrees, Medium, Serrated Handle, Polished Finish, Overall Length 3-3/8" (86mm)
Med Saver, Inc.
242-405-241
In Commercial Distribution

  • 00194613073695 ()


  • Intraocular scissors, conventional-hinge, reusable
Castroviejo Style Colibri Forceps, 0.5mm, 1 x 2 Teeth Set At 45 Degrees, 6mm Tying Platform, Serrated Wide Handle, Overall Length 4-1/4" (109mm)
Med Saver, Inc.
5-4316-5
In Commercial Distribution

  • 00194613039981 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Lewicky Cortex Extractor, 23ga, Polished Finish, 13mm Curved Shaft, 0.3mm Aspiration Port Set At 45 Degrees Left, Excluding Hub Overall Length 1-1/8" (34mm)
Med Saver, Inc.
5-5085-L
In Commercial Distribution

  • 00194613063627 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
LIFE®StartSystem replacement/spare cylinder. Includes cylinder, valve, gauge, and 113 liters of oxygen. Provides 15+ minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-O2-101
In Commercial Distribution

  • B188LIFEO21010 ()

  • Total Volume: 113 Liter


  • Oxygen refillable cylinder
NeuroBalloon™ NEUROBALLOON™ CATHETER
Integra LifeSciences Switzerland Sàrl
7CBD10
In Commercial Distribution

  • M2727CBD101 ()
  • 10381780035343 ()

  • Balloon waist diameter upon inflation: 3.5 mm minimum at 0.6 ml (0.6cc) of air, 6 mm maximum at 1 ml (1cc) of air; Cath. 60cm mini. Length; for insertion into a F4 minimum (1.35mm) diameter channel
7CBD10

  • Neural-tissue balloon catheter
n.a.
VBM Medizintechnik GmbH
65-88-130
In Commercial Distribution

  • 14250105602439 ()
  • 14250105628897 ()
  • 04250105602432 ()

  • Length: 18 cm / Tubing: 13 cm ; 15 mm I.D., 22 mm O.D. / 22 mm I.D. ; bronchoscope / suction cap (5.0 mm)


  • Breathing circuit catheter mount, reusable
n.a.
VBM Medizintechnik GmbH
65-50-130
In Commercial Distribution

  • 24250105628795 ()
  • 14250105628798 ()
  • 04250105602173 ()

  • Length: 17 cm / Tubing: 13 cm ; 15 mm I.D., 22 mm O.D. / 15 mm O.D.


  • Breathing circuit catheter mount, reusable
No Description
SOPRO-COMEG GmbH
391 410 017
In Commercial Distribution

  • 04059082014340 ()


  • Meniscus knife
No Description
SOPRO-COMEG GmbH
391 410 015
In Commercial Distribution

  • 04059082014326 ()


  • Meniscus knife
No Description
SOPRO-COMEG GmbH
391 410 016
In Commercial Distribution

  • 04059082014333 ()


  • Meniscus knife
Aggressive Meniscus Side Cutter
Karl Storz GmbH & Co. KG
28204BD
In Commercial Distribution

  • 04048551109465 ()


  • Meniscus knife
Aggressive Meniscus Cutter
Karl Storz GmbH & Co. KG
28204AZ
In Commercial Distribution

  • 04048551109403 ()


  • Meniscus knife
Aggressive Meniscus Cutter
Karl Storz GmbH & Co. KG
28204AA
In Commercial Distribution

  • 04048551109335 ()


  • Meniscus knife
Aggressive Meniscus Side Cutter
Karl Storz GmbH & Co. KG
28204BZ
In Commercial Distribution

  • 04048551109489 ()


  • Meniscus knife
Aggressive Meniscus Side Cutter
Karl Storz GmbH & Co. KG
28204BA
In Commercial Distribution

  • 04048551109410 ()


  • Meniscus knife
Aggressive Meniscus Cutter
Karl Storz GmbH & Co. KG
28204AD
In Commercial Distribution

  • 04048551109380 ()


  • Meniscus knife
Aggressive Meniscus Cutter
Karl Storz GmbH & Co. KG
28204AC
In Commercial Distribution

  • 04048551109366 ()


  • Meniscus knife
Catheter Mount Tubing for child
VBM Medizintechnik GmbH
65-00-090
Not in Commercial Distribution

  • 14250105600565 ()
  • 04250105600568 ()

  • Length: 9 cm ; 10 mm I.D. / 10 mm I.D.


  • Breathing circuit catheter mount, reusable
Sil-Flex tube 10F/22F,14cm
GaleMed Xiamen Co., Ltd.
77015
In Commercial Distribution

  • 44710810083301 ()
  • 24710810083307 ()
  • 04710810083303 ()


  • Breathing circuit catheter mount, reusable
smillie meniscus knife, 6 3/4" (17.0 cm), straight, chisel type
NOVO SURGICAL, INC.
N8861-14
In Commercial Distribution

  • 00842331144233 ()
N8861-14

  • Meniscus knife
smillie meniscus knife, 6 3/4" (17.0 cm), curved right
NOVO SURGICAL, INC.
N8861-13
In Commercial Distribution

  • 00842331154829 ()
N8861-13

  • Meniscus knife
smillie meniscus knife, 6 3/4" (17.0 cm), curved left
NOVO SURGICAL, INC.
N8861-12
In Commercial Distribution

  • 00842331154812 ()
N8861-12

  • Meniscus knife
downing cartilage knife, concave edge, curved blade, 10" (25.5 cm)
NOVO SURGICAL, INC.
N8861-23
In Commercial Distribution

  • 00842331181474 ()
N8861-23

  • Meniscus knife
No Description
AVID MEDICAL, INC.
UNVM146-04_0002
In Commercial Distribution

  • 20809160208943 ()
  • 10809160208946 ()
UNVM146-04

  • Neovaginoplasty kit
No Description
AVID MEDICAL, INC.
UNVM145-05_0002
In Commercial Distribution

  • 20809160209346 ()
  • 10809160209349 ()
UNVM145-05

  • Neovaginoplasty kit
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